Recent advances in drug delivery and formulation最新文献

{"title":"Preface.","authors":"Stefano Giovagnoli","doi":"10.2174/0126673878450996251028041734","DOIUrl":"10.2174/0126673878450996251028041734","url":null,"abstract":"","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"iv"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145484628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gallic Acid: A Potent Antioxidant and Anti-inflammatory Agent in Modern Cosmeceuticals.","authors":"Urvashi Saini, Anjali Sharma, Vishnu Mittal","doi":"10.2174/0126673878341990250516063126","DOIUrl":"10.2174/0126673878341990250516063126","url":null,"abstract":"<p><p>The cosmetics business is a valuable and stable multibillion-dollar business that keeps growing yearly with new, specialized goods. Natural goods contain a wealth of medicinally active chemicals used to treat a wide range of skin problems, including infections, inflammation, and damage caused by UV light and pollution. Cosmeceuticals are a mix of cosmetic and medical chemicals. Based on their main ingredients, they can be used for both beauty and health purposes. Many people think that natural goods are a great way to obtain cosmeceuticals. It has strong antiinflammatory, antibacterial, anti-cancer, and protective properties. The benefit for the skin has been said to be the most interesting. GA and its products have been used a lot as an adjuvant in many therapeutic formulations, as an alternative to hydro-cortisone in children with atopic dermatitis and other skin diseases, and as an ingredient in cosmetics because they are good for humans. GA is GRAS (generally recognized as safe) by the US Food and Drug Administration. Oxidative stress, which happens when too many free radicals build up, is the main cause of many skin diseases that get worse over time, like aging. Polyphenols, including gallic acid, represent a significant category of naturally occurring antioxidants. They have emerged as potent antioxidants suitable for incorporation into active makeup products. Recent advancements include patent filings related to novel applications and formulations of Gallic acid in cosmetic science that highlight innovative delivery systems, such as nano-formulations enhancing stability and efficacy, as well as its synergistic combinations with other active ingredients to address targeted skin concerns like pigmentation, aging, and sensitivity which meets the demands of modern consumers.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"21-40"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144182899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing Drug Stability Using Non-Aqueous Gels: Properties, Applications, and Emerging Challenges.","authors":"Jabin Ahmed, Aians H Kalita, Ghanshyam Das Gupta, Shubham Thakur","doi":"10.2174/0126673878371228250519073422","DOIUrl":"10.2174/0126673878371228250519073422","url":null,"abstract":"<p><p>This study explores the emerging potential of non-aqueous gels for topical therapy, examining their unique properties, diverse applications, and the challenges involved in their formulation and clinical use. By highlighting these aspects, the article aims to shed light on the future of localized drug delivery and inspire further research and innovation in this promising field. Additionally, the article addresses the critical need for regulatory considerations, stability testing, and patient acceptability. It also emphasizes the role of non-aqueous gels in revolutionizing dermatological and transdermal therapies, particularly by enhancing the stability of drugs that are hydrolyzed in the presence of water.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144145393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the Therapeutic Potential of Crisaborole Gel in Atopic Dermatitis: A Review.","authors":"Charu Saxena, Chirag Tyagi","doi":"10.2174/0126673878342969251128064804","DOIUrl":"10.2174/0126673878342969251128064804","url":null,"abstract":"<p><p>Atopic Dermatitis (AD) is a long-lasting, inflammatory, and itchy skin disease related to asthma, hay fever, and a family history of the condition. It is the most common chronic skin disease in children, affecting 18% of 7-year-olds. The prevalence of AD in children in the United States is 17.2%, which is comparable to that in Europe and Japan. Greater socioeconomic groupings, fewer families, and metropolitan areas all have higher AD prevalence rates. It is thought that a mix of environmental and genetic factors produces the condition. The gene that codes for the skin matrix protein filaggrin is the most strongly linked genetic link currently identified with AD. Increased water loss due to AD-induced breakdown of the skin barrier leads to dry skin, heightening vulnerability to microbial colonization, allergy sensitization, and infection. PDE4, an intracellular enzyme present in inflammatory cells, is greater in persons with active AD and latent allergic rhinitis. Consequently, crisaborole, a PDE4 inhibitor, raises intracellular cAMP levels, activating Protein Kinase A (PKA), suggesting potential therapeutic options for the dysregulated inflammatory cycle associated with this disease. Thus, Crisaborole should be regarded as the safest and most effective option for treating atopic dermatitis. Crisaborole's specific mechanism, safety profile, and effectiveness in interrupting the inflammatory cycle make it an attractive treatment alternative, according to this study. Crisaborole is presented here as a potential remedy to address the research gap: the need for safer, more efficient therapies that target inflammatory pathways in AD.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"300-310"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146055619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comprehending the Potential of Topical Therapies for the Treatment of Onychomycosis.","authors":"Shivangi Verma, Naveen Kumar, Aman Sharma, Shweta Agarwal","doi":"10.2174/0126673878340909250628080713","DOIUrl":"10.2174/0126673878340909250628080713","url":null,"abstract":"<p><strong>Introduction: </strong>Onychomycosis is a frequently occurring fungal infection that affects the nails of the fingers and toes. Infection is caused by yeasts, dermatophytes, and nondermatophyte molds. Onychomycosis should be confirmed by mycology. Diagnosis can be made by various techniques, such as microscopy, fungal culture, potassium hydroxide, polymerase chain reaction, and histopathology. This review was undertaken to study the challenges associated with topical therapy of onychomycosis and techniques to overcome these challenges.</p><p><strong>Methods: </strong>The search engines used for carrying out the literature review were PubMed, Google, Scopus, and Google Scholar. The search terms employed were \"topical therapies for onychomycosis\", \"diagnosis of onychomycosis\", and \"challenges in the treatment of onychomycosis\". The data related to topical treatments were compiled, and articles available in English language were only considered.</p><p><strong>Results and discussion: </strong>The main challenge associated with topical therapy was found to be the unique structure of the nails, hampering drug penetration to the infection site and inducing fungal drug resistance. Conventional treatment methods, as well as novel techniques developed for topical therapy, like microporation, ionotophoresis, laser, and photodynamic therapy, have also been explored. Oral antifungals are most commonly used for moderate to severe onychomycosis as they provide greater cure rates, whereas topical application of antifungals is advocated for mild to moderate infections as it possesses a better safety profile. Efinaconazole solution (10%), tavaborole solution (5%), and ciclopirox nail lacquer (8%) for topical use are accepted by the Food and Drug Administration (FDA) for the management of onychomycosis. Laser treatment is approved in the United States for the short-term improvement of clear nails in fungal infections, but the clinical outcomes have not yet reached optimal levels.</p><p><strong>Conclusion: </strong>Topical therapy can be considered a treatment option for mild to moderate onychomycosis, even though effective delivery of the drug is restricted by the nail's barrier properties. However, further clinical studies are required to establish their long-term efficacy.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"93-104"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144639227","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Formulation and Characterization of Multiparticulate System for Proton Pump Inhibitor using Combination Therapy for Peptic Ulcer.","authors":"Prince Nikhil Rathore, Alpana Ram","doi":"10.2174/0126673878360081250628164032","DOIUrl":"10.2174/0126673878360081250628164032","url":null,"abstract":"<p><strong>Introduction: </strong>The purpose of this study was to develop sustained-release enteric-coated granules of Amla extract and esomeprazole magnesium for the treatment of peptic ulcer. It is well known that Amla possesses anti-ulcer activity due to the phenolic compound gallic acid, which inhibits a gastric H+/K+ ATPase pump. Therefore, enteric-coated Amla extract granules were combined with esomeprazole magnesium granules to enhance the synergistic effect, mitigate adverse effects associated with esomeprazole magnesium, and improve overall anti-ulcer activity, while the enteric-coated multiparticulate system ensures prolonged drug release with a minimum dose.</p><p><strong>Methods: </strong>A Soxhlet extraction method was employed to obtain the Amla phenolic extract, using a solvent mixture of ethanol and water in a 7:3 ratio. Wet granulation techniques were utilized to prepare granules, and hydroxypropyl methylcellulose phthalate served as the enteric coating agent. The in vitro drug release and drug entrapment were used to optimize the enteric-coated granules of Amla extract and Esomeprazole Magnesium. An in vivo study was conducted in Wistar albino rats (120-140 g) of both sexes to demonstrate the antiulcer activity of the developed formulation against an aspirin-induced ulcerated rat model.</p><p><strong>Results: </strong>Both in vitro and in vivo studies were conducted. In the in vitro studies, drug release was assessed at pH 1.2 (simulated gastric fluid) and pH 6.8 (simulated intestinal fluid). The results demonstrated negligible drug release in the simulated gastric fluid due to the protective enteric coating, while efficient drug release occurred in the simulated intestinal fluid. In the in vivo studies, the combination therapy showed a significant therapeutic effect compared to other treatment groups in an animal model.</p><p><strong>Discussion: </strong>Amla extract and esomeprazole magnesium were combined to prepare sustainedrelease enteric-coated granules for the treatment of peptic ulcers. The phenolic substance gallic acid inhibits the gastric H+/K+ ATPase pump, thereby enhancing anti-ulcer efficacy. The combination demonstrated substantial therapeutic efficacy in both in vitro and in vivo investigations.</p><p><strong>Conclusion: </strong>The amla extract and esomeprazole magnesium enteric-coated granules with sustained release and negligible drug release in acidic pH were achieved. In the in vivo studies, the combination therapy demonstrated a significant positive effect in treating peptic ulcers in a rat ulcer model, as shown by assessments of various parameters such as ulcer index, total gastric juice acidity, hematological analysis, and histopathological evaluations.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"153-181"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144639181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recent Expansions and Future Outlook in the Delivery of Poorly Soluble Phytoconstituents through Solid Dispersion Technique.","authors":"Bhavesh Sahu, Kalyani Sakure, Ajazuddin, Hemant Badwaik","doi":"10.2174/0126673878341183250514112919","DOIUrl":"10.2174/0126673878341183250514112919","url":null,"abstract":"<p><p>Phytoconstituents, derived from plants, possess significant therapeutic potential but often face challenges such as poor solubility and low bioavailability, limiting their efficacy. Solid dispersion (SD) is a promising approach to improve the solubility and bioavailability of these poorly water- soluble phytoconstituents. By dispersing the active drug in a hydrophilic carrier, solid dispersion enhances the surface area of the drug, improving its dissolution rate and enhancing absorption. This review provides an overview of the various generations of solid dispersions, highlighting the evolution from crystalline carriers in first-generation solid dispersions to the more advanced amorphous solid solutions in second and third-generation formulations, which offer enhanced solubility and bioavailability. The article also discusses various techniques for preparing solid dispersions, including solvent evaporation, melting, and spray-drying methods, and emphasizes the importance of selecting appropriate carriers, such as hydrophilic polymers, to optimize the dissolution rate of phytoconstituents. The study highlighted the recent case studies on several phytochemicals, like alkaloids, glycosides, Polyphenols, etc., demonstrating the effectiveness of solid dispersion in improving their solubility and therapeutic performance. Additionally, the review addresses the challenges related to the solubility of phytoconstituents and their impact on drug absorption, as well as the role of solid dispersion in overcoming these challenges. Overall, solid dispersion technology emerges as a versatile and effective tool for enhancing the oral bioavailability of phytoconstituents, paving the way for more efficient herbal therapies in modern medicine.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"221-231"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144145342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Navigating Regulatory Complexities in Biosimilar Approvals and Imports for Autoimmune Disorder Management: A Comparative Analysis of FDA (US), EMA (EU), and CDSCO (India) Guidelines.","authors":"S John Gerard, Vasukidevi Ramachandran","doi":"10.2174/0126673878360952250715031025","DOIUrl":"10.2174/0126673878360952250715031025","url":null,"abstract":"<p><p>Biosimilars offer cost-effective alternatives for autoimmune disorder treatment. However, India's stringent regulatory barriers, including mandatory local trials, unclear interchangeability guidelines, and strict pricing controls, hinder market access. This study conducts a comparative analysis of the FDA (US), EMA (EU), and CDSCO (India) regulatory frameworks, highlighting key differences in approval pathways, post-marketing surveillance, and import regulations. Unlike previous studies, this paper employs a structured SWOT analysis to assess the impact of India's regulatory landscape on biosimilar accessibility. The findings reveal that India's local clinical trial mandates and complex approval processes hinder biosimilar adoption despite prior FDA or EMA approvals. Additionally, the absence of interchangeability guidelines discourages physician confidence, while stringent pricing policies under the Drug Price Control Order (DPCO) reduce manufacturer incentives. To improve biosimilar market penetration, India must streamline regulatory approvals, harmonize clinical trial requirements with international standards, and establish clear interchangeability guidelines. These reforms are essential to enhance the affordability and accessibility of biosimilars in the management of autoimmune disorders.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"232-249"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144786346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying Optimized Parameters to Enhance the Productivity of Gas Generating Pellets Using a Dome Type Extruder.","authors":"Ronak R Patel, Dharmik M Mehta","doi":"10.2174/0126673878351312250502072134","DOIUrl":"10.2174/0126673878351312250502072134","url":null,"abstract":"<p><strong>Introduction: </strong>The extrusion-spheronization process continues to be utilized in pharmaceutical manufacturing, as evidenced by several recent patents and articles. The primary challenge in pelletization via extrusion spheronization is optimizing the production process to achieve high yields of spherical pellets while keeping production costs low. Therefore, this study aimed to identify the ideal parameters for maximizing production rates using a dome extruder while maintaining the desired physical characteristics of the pellets.</p><p><strong>Methods: </strong>The pellet formulation comprised apixaban, microcrystalline cellulose, hypromellose, and sodium bicarbonate. The study employed the face-centered central design to assess the impact of various process variables. Key factors included extruder speed, spheronization speed, and spheronization time, which were determined based on the preliminary analyses. Characterization of pellets encompassed measurements of sphericity via aspect ratio, friability, bulk density, and percentage yield.</p><p><strong>Results: </strong>The optimized parameters for extrusion speed spanned from 23 to 27 rpm, while spheronization speed extended from 700 to 900 rpm at 5 min to 7 min of spheronization time, yielding more than 90% of the desired fraction of spherical pellets with good physical properties.</p><p><strong>Discussion: </strong>It was discerned that extrusion and spheronization speed emerged as critical process parameters within a defined spheronization time for maximizing production rates while concurrently maintaining satisfactory pellet properties.</p><p><strong>Conclusion: </strong>This study successfully optimized process parameters for pellet production using a dome-type extruder by employing a Quality by Design (QbD) approach. Key factors influencing pellet yield and quality, such as extrusion speed, spheronization speed, and time, were identified and systematically optimized.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"137-152"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144056493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global and Indian Regulatory Frameworks for Pharmaceutical Excipients, APIs, and Formulations: Challenges and Harmonization Strategies.","authors":"P Dhinesh Pandian, Rajaganapathy Kaliyaperumal","doi":"10.2174/0126673878362406250607104550","DOIUrl":"10.2174/0126673878362406250607104550","url":null,"abstract":"<p><p>Pharmaceutical excipients play a critical role in drug formulation, ensuring stability, bioavailability, manufacturability, and patient safety. While India has made progress in aligning with international excipient regulations, significant regulatory gaps persist, including inconsistent enforcement, lack of mandatory GMP compliance, and inadequate impurity testing standards. These challenges create quality inconsistencies and potential safety risks, particularly for high-risk excipients. Indian excipient manufacturers face difficulties meeting international regulatory expectations, such as FDA, EMA, and PMDA requirements, due to differences in documentation, quality control, and risk assessment standards. Case studies highlight successful compliance strategies, including supplier qualification, in-house impurity testing, and risk-based categorization. To strengthen excipient regulation, mandatory GMP certification, a risk-based excipient categorization system, and alignment with IPEC-PQG, WHO, and ICH Q7 guidelines are recommended. Additionally, CDSCO must enhance oversight through advanced impurity testing and improved traceability requirements. Ensuring regulatory harmonization with global standards will enhance India's competitiveness in the excipient supply chain, facilitate international market access, and improve overall drug safety and efficacy. This review underscores the urgent need for structured regulatory reforms to streamline compliance, ensure excipient quality, and strengthen India's position in the global pharmaceutical industry.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":"81-92"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144328307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}